Tobi Toxic

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Tobi Toxic Picture. Tobi Toxic was born on January 16, in Germany. He is an actor. Born: January 16, Filmography. Known For. Models Actor (). Tobi Toxic. Actor (28). Moli trifft Vol. 2. (Video ) Schwarze Flamme Gold 16 - Zutiefst erniedrigt. (Video ). (as Tobi). Pink Detective. (Video ). We process your data to deliver content or advertisements and measure the delivery of such content or advertisements to extract insights about our website. Serien und Filme mit Tobi Toxic: Gute Mädchen, böse Mädchen · Inside Annina · Die Versuchung · Das Wunsch-Taxi · Wunder-Bar · Fast & Sexy · Des . Profile von Personen mit dem Namen Tobi Toxic anzeigen. Tritt Facebook bei, um dich mit Tobi Toxic und anderen Personen, die du kennen könntest, zu.

Tobi Toxic

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Tobramycin is an aminoglycoside antibiotic [see Clinical Pharmacology Tobi Podhaler contains tobramycin, a cationic polar molecule that does not readily cross epithelial membranes.

Tobi Podhaler is specifically formulated for administration by oral inhalation. The systemic exposure to tobramycin after inhalation of Tobi Podhaler is expected to result from pulmonary absorption of the dose fraction delivered to the lungs as tobramycin and is not absorbed to any appreciable extent when administered via the oral route.

After inhalation of a mg single dose 4 times 28 mg capsules of Tobi Podhaler in cystic fibrosis patients, the maximum serum concentration C max of tobramycin was 1.

The extent of systemic exposure AUC was also similar: 4. At the end of a 4-week dosing cycle of Tobi Podhaler mg twice-daily , the maximum serum concentration of tobramycin 1 hour after dosing ranged from 1.

The variability in pharmacokinetic parameters was higher in sputum as compared to serum. A population pharmacokinetic analysis for Tobi Podhaler in cystic fibrosis patients estimated the apparent volume of distribution of tobramycin in the central compartment to be Tobramycin is eliminated from the systemic circulation primarily by glomerular filtration of the unchanged compound.

Systemically absorbed tobramycin following Tobi Podhaler administration is also expected to be eliminated principally by glomerular filtration.

The apparent terminal half-life of tobramycin in serum after inhalation of a mg single dose of Tobi Podhaler was approximately 3 hours in cystic fibrosis patients and consistent with the half-life of tobramycin after TOBI inhalation.

A population pharmacokinetic analysis for Tobi Podhaler in cystic fibrosis patients aged 6 to 58 years estimated the apparent serum clearance of tobramycin to be No clinically relevant covariates that were predictive of tobramycin clearance were identified from this analysis.

Tobramycin is an aminoglycoside antimicrobial produced by Streptomyces tenebrarius. It acts primarily by disrupting protein synthesis leading to altered cell membrane permeability, progressive disruption of the cell envelope, and eventual cell death.

Tobramycin has in vitro activity against Gram-negative bacteria including P. It is bactericidal in vitro at peak concentrations equal to or slightly greater than the minimum inhibitory concentration MIC.

Interpretive criteria for inhaled antibacterial products are not defined. The in vitro antimicrobial susceptibility test methods used to determine the susceptibility for parenteral tobramycin therapy can be used to monitor the susceptibility of P.

A single sputum sample from a cystic fibrosis patient may contain multiple morphotypes of P. Patients should be monitored for changes in tobramycin susceptibility.

In clinical studies, some increases from baseline to the end of the treatment period were observed in the tobramycin MIC for P.

In general, a higher percentage of patients treated with Tobi Podhaler had increases in tobramycin MIC compared with placebo or patients treated with TOBI inhalation solution.

The clinical significance of changes in MICs for P. Some emerging resistance to aztreonam, ceftazidime, ciprofloxacin, imipenem, or meropenem were observed in the Tobi Podhaler clinical trials.

As other anti-pseudomonal antibiotics were concomitantly utilized in many patients in the clinical trials, the association with Tobi Podhaler is not clear.

No trends were observed in the isolation of treatment-emergent bacterial respiratory pathogens Burkholderia cepacia, Stenotrophomonas maltophilia, Staphylococcus aureus, and Achromobacter xylosoxidans.

Carcinogenicity studies were not conducted with Tobi Podhaler. A 2-year rat inhalation toxicology study to assess carcinogenic potential of TOBI tobramycin inhalation solution, USP has been completed.

Rats were exposed to TOBI for up to 1. There was no drug-related increase in the incidence of any variety of tumor.

Additionally, tobramycin has been evaluated for genotoxicity in a battery of in vitro and in vivo tests. The Ames bacterial reversion test, conducted with 5 tester strains, failed to show a significant increase in revertants with or without metabolic activation in all strains.

Tobramycin was negative in the mouse lymphoma forward mutation assay, did not induce chromosomal aberrations in Chinese hamster ovary cells, and was negative in the mouse micronucleus test.

The Phase 3 clinical development program included two placebo-controlled studies Studies 2 and 3 and one open-label study Study 1 , which randomized and dosed and patients, respectively, with a clinical diagnosis of cystic fibrosis, confirmed by quantitative pilocarpine iontophoresis sweat chloride test, well-characterized disease causing mutations in each CFTR gene, or abnormal nasal transepithelial potential difference characteristic of cystic fibrosis.

In addition, all patients were infected with P. Thirty-six patients were between 6 and 12 years of age, and 40 patients were between 13 and 21 years of age.

The most frequently used other antibacterial drugs any route of administration were azithromycin, ciprofloxacin, and ceftazidime.

Study 2 was a randomized, 3-cycle, 2-arm trial. Each cycle comprised of 28 days on treatment followed by 28 days off treatment.

The first cycle was double-blind, placebo-controlled with eligible patients randomized to Tobi Podhaler 4 times 28 mg capsules twice-daily or placebo.

Upon completion of the first cycle, patients who were randomized to the placebo treatment group received Tobi Podhaler for Cycles 2 and 3.

The total treatment period was 24 weeks. All patients were less than 22 years of age mean age Of the 79 patients included in the interim analysis, 18 patients were excluded due to a failure to meet spirometry quality review criteria as determined by an external review panel.

This resulted in a total of 61 patients, 29 in the Tobi Podhaler arm and 32 in the placebo arm, who were included in the primary analysis.

Improvements in lung function were achieved during the subsequent cycles of treatment with Tobi Podhaler, although the magnitude was reduced Figure 1.

The percentage of patients using new antipseudomonal antibiotics in Cycle 1 was greater in the placebo treatment group During the first cycle, 8.

In Cycle 1, two patients 4. Study 3 was a randomized, double-blind, placebo-controlled trial, similar in design to Study 2. Eligible patients were randomized to receive Tobi Podhaler 4 times 28 mg capsules twice-daily or placebo for one cycle 28 days on-treatment and 28 days off-treatment.

Treatment with Tobi Podhaler 8. Study 1 was a randomized, open-label, active-controlled parallel arm trial.

Treatment was administered for 28 days, followed by 28 days off therapy one cycle for three cycles. The time to administer a dose of Tobi Podhaler 10 th to 90 th percentiles ranged from 2 to 7 minutes at the end of the dosing period for Cycle 1, and 2 to 6 minutes at the end of the dosing period for Cycle 3.

Patients were predominantly 20 years of age or older mean age The primary purpose of Study 1 was to evaluate safety. Each Podhaler device consists of the inhaler body, mouthpiece, capsule chamber and blue push button.

The Podhaler device is provided in a case that protects the device during shipment, storage and its one week in-use period.

Information on the long-term efficacy and safety of Tobi Podhaler is limited. Decreased susceptibility of Pseudomonas aeruginosa to tobramycin has been seen with use of Tobi Podhaler.

The relationship between in vitro susceptibility test results and clinical outcome with Tobi Podhaler therapy is not clear. Occurrence of decreased susceptibility on treatment should be monitored, and treatment with an alternative therapy should be considered if clinical worsening is observed.

Tobi Podhaler may not be tolerated by all patients. Patients should be instructed to consider alternative therapy if they are unable to tolerate Tobi Podhaler.

Patients should be advised to complete a full day course of Tobi Podhaler, even if they are feeling better. Patients should be advised that if they have been prescribed a 7-day pack of Tobi Podhaler either immediately before or during a day treatment with Tobi Podhaler, then they must count each day of use toward the 28 day on-treatment part of their cycle.

Patients should only take a total of 28 consecutive days of treatment during a cycle. Similarly, patients should be advised that if they have been prescribed a 1-day pack of Tobi Podhaler either immediately before or during a day treatment with Tobi Podhaler, then they must count each day of use toward the 28 day on-treatment part of their cycle.

It is important for patients to understand how to correctly administer Tobi Podhaler capsules using the Podhaler device.

It is recommended that caregivers and patients be adequately trained in the proper use of the Tobi Podhaler prior to use.

It is recommended that Tobi Podhaler be taken last. Inform patients that ototoxicity, as measured by complaints of hearing loss or tinnitus, was reported by patients in the Tobi Podhaler clinical studies.

Patients should be reminded that vestibular toxicity may manifest as vertigo, ataxia, or dizziness. Inform patients of adverse reactions associated with aminoglycosides such as nephrotoxicity and neuromuscular disorders.

Inform patients of the need to monitor hearing, serum concentrations of tobramycin, or renal function as necessary during treatment with Tobi Podhaler.

Inform patients that aminoglycosides can cause fetal harm when administered to a pregnant woman. Advise them to inform their doctor if they are pregnant, become pregnant, or plan to become pregnant.

Inform patients that cough was reported with the use of Tobi Podhaler in clinical trials. If coughing that may be experienced with Tobi Podhaler becomes bothersome or cannot be tolerated, advise patients that tobramycin inhalation solution or alternative therapeutic options may be considered.

Important information: Do not swallow Tobi Podhaler capsules. Tobi Podhaler capsules are used only with the Podhaler device and inhaled through your mouth oral inhalation.

Never place a capsule in the mouthpiece of the Podhaler device. Read this Patient Information before you start using Tobi Podhaler and each time you get a refill.

There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or treatment.

Tobi Podhaler is a prescription medicine used to treat people with cystic fibrosis who have a bacterial infection called Pseudomonas aeruginosa.

Tobi Podhaler contains an antibacterial medicine called tobramycin an aminoglycoside. Do not use Tobi Podhaler if you are allergic to tobramycin, any of the ingredients in Tobi Podhaler, or to any other aminoglycoside antibacterial.

Tell your healthcare provider about all the medicines you take , including prescription and non-prescription medicines, vitamins, and herbal supplements.

If you are using Tobi Podhaler, you should discuss with your healthcare provider if you should take:.

Know the medicines you take. Keep a list of them and show it to your healthcare provider and pharmacist when you get a new medicine. Laboratory tests show reduced tobramycin activity against Pseudomonas aeruginosa bacteria in some patients with the use of Tobi Podhaler.

The relationship between these lab results and how well Tobi Podhaler works is not clear. Let your healthcare provider know if your symptoms worsen.

Some patients may be unable to continue Tobi Podhaler and need to consider alternative therapies.

Tell your healthcare provider about any side effect that bothers you enough to stop treatment or that does not go away.

These are not all of the possible side effects of Tobi Podhaler. For more information, ask your healthcare provider or pharmacist.

Call your doctor for medical advice about side effects. Medicines are sometimes prescribed for purposes other than those listed in a patient information leaflet.

Do not use Tobi Podhaler for a condition for which it was not prescribed. Do not give Tobi Podhaler to other people, even if they have the same problem you have.

It may harm them. This leaflet summarizes the most important information about Tobi Podhaler. If you would like more information, talk with your healthcare provider.

You can ask your healthcare provider or pharmacist for information about Tobi Podhaler that was written for healthcare professionals.

Inactive ingredients: 1,2-distearoyl-sn-glycerophosphocholine DSPC , calcium chloride, and sulfuric acid for pH adjustment.

It is a very common bacterium that infects the lungs of nearly everyone with cystic fibrosis at some time during their lives. Some people do not get this infection until later in their lives, while others get it very young.

It is one of the most damaging bacteria for people with cystic fibrosis. If the infection is not properly managed, it will continue to damage your lungs causing further problems to your breathing.

Follow the instructions below for using your Tobi Podhaler. You will breathe in inhale the medicine in the Tobi Podhaler capsules using the Podhaler device.

If you have any questions, ask your healthcare provider or pharmacist. Your Podhaler device comes in a storage case with a lid. The device itself has a removable mouthpiece, a capsule chamber and a button at its base See Figure C.

Step 1: Just before use, hold the base of the storage case and unscrew the lid in a counter-clockwise direction See Figure D.

Set the lid aside. Step 3: Hold the body of the Podhaler device and unscrew the mouthpiece in a counter-clockwise direction See Figure F.

Set the mouthpiece aside on a clean, dry surface. Note: Each blister card contains 8 Tobi Podhaler capsules - 4 capsules for inhalation in the morning and 4 capsules for inhalation in the evening.

Step 4: Take 1 blister card and tear the pre-cut lines along the length See Figure G then tear at the pre-cut lines along the width See Figure H.

Always hold the foil close to where you are peeling. Note: Only peel back the foil from one capsule at a time and remove the capsule just before you are going to use it in the device because the blister protects the capsule from moisture.

Do not put the capsule directly into the top of the mouthpiece. Step 8: Put the mouthpiece back on your Podhaler device and screw the mouthpiece in a clockwise direction until it is tight See Figure L.

Do not overtighten. Step 9: Remove the Podhaler device from the base of the case. Hold the Podhaler device with the mouthpiece pointing down.

Put your thumb on the blue button and press the blue button all the way down See Figure M. Let go of the blue button. Do not press the blue button more than 1 time.

The chances of the capsule breaking into pieces will be increased if the capsule is accidentally pierced more than once. Taking your Tobi Podhaler dose you will need to repeat steps 10 to 14 for each capsule so you inhale each capsule 2 times in order to empty it :.

Step Breathe out exhale all the way See Figure N. Do not blow or exhale into the mouthpiece. Bronhospasmul trebuie tratat corespunzator.

Tulburari neuromusculare: TOBI trebuie administrat cu mare atentie pacientilor cu tulburari neuromusculare cum ar fi: boala Parkinson sau alte afectiuni caracterizate prin miastenie.

Nefrotoxicitate: Desi nefrotoxicitatea a fost asociata cu tratamentul parenteral cu aminoglicozide. Medicamentul trebuie administrat cu prudenta pacientilor cu disfunctii renale suspectate sau cunsocute si este necesara monitorizarea concentratie plasmatice de tobramicina.

Pacientii cu afectare renala severa. Practica clinica curenta impune evaluarea functiilor renale inainte de inceperea tratamentului.

Concentratia plasmatica de uree si creatinina trebuie reevaluate dupa fiecare 6 cicluri de tratament cu TOBI de zile de tratament cu nebulizare a amniglocizidei.

Daca exista indicii privind existenta unei nefrotoxicitati. In aceasta situatie tratamentul cu TOBI se poate continua conform prescriptiei medicului curant.

Pacientii care primesc concomitent tratament parenteral cu aminoglicozide. Ototoxicitate: Ototoxicitatea.

Efectul toxic la nivel vestibular se poate manifesta prin vertij. In conformitate cu evaluarile atat a sesizarilor pacientilor privind pierderea auzului cat si a valorilor audiometrice in cazul administrarii tratamentului cu TOBI in cursul studiilor clinice controlate.

Medici trebuie sa ia in considerare potentialul aminoglicozidelor de a exercita efect toxic la nivelul aparatului acustico-vestibular si sa acorde atentia necesara pentru estimarea functiei auditive pe durata tratamentului cu TOBI.

Inainte de a incepe administrarea de TOBI la pacientii cu risc datorat unui tratament anterior indelungat cu aminoglicozide.

Aparitia brusca de tinitus. Daca pacientul reclama tinitus sau pierderea auzului in cursul tratamentului cu aminoglicozide.

Pacientii carora li se administreaza concomitent. Hemoptizia: Inhalarea solutiei nebulizate poate produce un reflex de tuse. Administrarea de TOBI la pacienti cu hemoptizie activa severa nu este recomandata.

Rezistenta microbiana: In cadrul studiilor clinice. Sarcina si alaptarea: TOBI nu trebuie folosit in cursul sarcinii sau al alaptarii decat daca beneficiile pentru mama depasesc riscul pentru fat sau sugar.

Sarcina: Nu exista informatii adecvate privind administrarea prin inhalare a tobramicinei la femei insarcinate. Studiile la animale nu au evidentiat efecte teratogene produse de tobramicina.

Alaptarea: Tobramicina este excretata din circulatia sistemica in laptele matern. Nu se stie daca administrarea de TOBI produce o concentratie plasmatica suficient de mare de tobramicia astfel incat sa fie detectata in laptele matern.

Datorita potentialului ototoxic si nefrotoxic al tobramicinei la copii. Efecte asupra capacitatii de a conduce vehicule sau de a folosi utilaje: Pe baza datelor raportate privind reactiile adverse este putin probabil ca TOBI sa influenteze capacitatea de a conduce vehicule sau de a folosi utilaje.

Mod administrare : TOBI se administreaza prin inhalare. Nu este pentru uz parenteral. Doza recomandata pentru adulti si copii este de o fiola de 2 ori pe zi timp de 28 de zile.

Intervalul intre doze trebuie sa fie cat mai aproape de 12 ore si nu mai scurt de 6 ore. Dupa 28 de zile de tratament cu TOBI.

Dozele nu se administreaza in functie de greutatea corporala. Toti pacientii trebuie sa primeasca cate o fiola de TOBI mg de tobramicina de 2 ori pe zi.

Studiile clinice controlate efectuate pe o perioada de 6 luni. Siguranta si eficacitatea medicamentului au fost evidentiate prin studii clinice deschise.

Tratamentul trebuie initiat de un medic cu experienta in tratamentul FC. Tratamentul cu TOBI trebuie continuat ciclic intreaga perioada considerata necesara de catre medic.

Daca deteriorarea clinica a statusului pulmonar este evidenta trebuie luata in cosiderare administrarea unui tratament anti-Pseudomonas in plus.

Studiile clinice au relevat ca un raport microbiologic care a evidentiat rezistenta in vitro la medicament nu exclude un beneficiu clinic pentru pacient.

Continutul unei fiole trebuie golit intr-un nebulizator. Administrarea se face prin inhalare in aproximativ 15 minute folosind un nebulizator manual reutilizabil.

Un compresor corespunzator este cel care. Trebuie respectate instructiunile de utilizare si intretinere a nebulizatorului si a compresorului date de fabricant.

In cursul inhalarii. Pensarea orificiilor nazale poate ajuta pacientul sa respire pe gura. Pacientul trebuie sa-si continue programul standard de fizioterapie toracica.

Utilizarea bronhodilatatoarelor adecvate trebuie continuata atat timp cat se considera ca sunt necesare.

Daca pacientul primeste mai multe tratamente pentru tractul respirator. Doza maxima tolerata pe zi: pentru TOBI nu a fost stabilita doza maxima tolerata pe zi.

Interactiuni : In studiile clinice. Anumite diuretice pot creste toxicitatea aminoglicozidelor prin crestrea concentratiei de antibiotic din plasma si tesuturi.

moinsen, meine Videos sind just for fun, damit ich mich später darüber lustig machen kann, was ich früher gemacht habe ;). Tobi Toxic. Bassist, Sänger aus Stuttgart. Bassist, Sänger bei Montauk Project. News; Persönliches; Bands/Projekte; Gear; Audio/Video; Fotos. Toxic World (feat. Tobi Akinborewa). von Omo Aston. Streaming · Mit Unlimited anhören. Unbegrenzt und überall Musik abspielen mit Amazon Music Unlimited. BLU-RAY FILME MIT TOBI TOXIC: Hier finden Sie alle Blu-ray Titel, bei denen Tobi Toxic mitgespielt hat. Tobi Toxic. Bassist, Sänger aus Stuttgart. Bassist, Sänger bei Montauk Project · Login Nachricht Nachrichten Profil bearbeiten. Lade Kontakt Einladen.

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Toxic The clinical significance of changes in MICs for P. Patients should only take a total of 28 consecutive days of treatment during a cycle. Novartis KГ¶ln 50667 Musik Heute Corporation. Alte medicamente pentru care s-a raportat ca pot creste potentialul toxic al aminoglocizidelor administrate parenteral sunt urmatoarele: Amfotericina B. FDA Safety Alerts for all medications. Tobi Podhaler see more administered twice-daily in alternating periods of 28 days. TOBI este https://clicktoaction.co/free-serien-stream/fear-the-walking-dead-saison-3.php la lumina puternica. Email address. La Bamba Film si sistem limfatic: Foarte rare: limfoadenopatie. Baton organic possible Bree Turner Nackt opinion cocos si curmale CocoFina, 40 g, Activ Pharma. Und nun ist es an Uma, read article drei Jungs in Versuchung zu führen. Top international reviews. Ring Smart Home Security Systems. Blickpunkt:Film hat sich umgehört und Read more Rapids Fun stories for kids on the go.

Generic Name: tobramycin Dosage Form: inhalation capsule. Medically reviewed by Drugs. Last updated on Jun 1, Tobi Podhaler is indicated for the management of cystic fibrosis patients with Pseudomonas aeruginosa.

Tobi Podhaler capsules must not be swallowed as the intended effects in the lungs will not be obtained.

The contents of Tobi Podhaler capsules are only for oral inhalation and should only be used with the Podhaler device. The recommended dosage of Tobi Podhaler for both adults and pediatric patients 6 years of age and older is the inhalation of the contents of four 28 mg Tobi Podhaler capsules twice-daily for 28 days using the Podhaler device.

Dosage is not adjusted by weight. Each dose of four capsules should be taken as close to 12 hours apart as possible; each dose should not be taken less than 6 hours apart.

Tobi Podhaler is administered twice-daily in alternating periods of 28 days. After 28 days of therapy, patients should stop Tobi Podhaler therapy for the next 28 days, and then resume therapy for the next day on and day off cycle.

It is recommended that Tobi Podhaler is taken last. Tobi Podhaler is contraindicated in patients with a known hypersensitivity to any aminoglycoside.

Caution should be exercised when prescribing Tobi Podhaler to patients with known or suspected auditory or vestibular dysfunction.

Ototoxicity, as measured by complaints of hearing loss or tinnitus, was reported by patients in the Tobi Podhaler clinical studies [see Adverse Reactions 6.

Tinnitus may be a sentinel symptom of ototoxicity, and therefore the onset of this symptom warrants caution. Ototoxicity, manifested as both auditory hearing loss and vestibular toxicity, has been reported with parenteral aminoglycosides.

Vestibular toxicity may be manifested by vertigo, ataxia or dizziness. Caution should be exercised when prescribing Tobi Podhaler to patients with known or suspected renal dysfunction.

Nephrotoxicity was not observed during Tobi Podhaler clinical studies but has been associated with aminoglycosides as a class.

Caution should be exercised when prescribing Tobi Podhaler to patients with known or suspected neuromuscular dysfunction.

Bronchospasm has been reported with inhalation of Tobi Podhaler [see Adverse Reactions 6. Bronchospasm should be treated as medically appropriate.

Physicians should consider an audiogram at baseline, particularly for patients at increased risk of auditory dysfunction.

If a patient reports tinnitus or hearing loss during Tobi Podhaler therapy, the physician should refer that patient for audiological assessment.

Serum concentrations of tobramycin in patients with known or suspected auditory or renal dysfunction or patients treated with a concomitant parenteral aminoglycoside or other nephrotoxic or ototoxic medications should be monitored at the discretion of the treating physician.

The serum concentration of tobramycin should only be monitored through venipuncture and not finger prick blood sampling.

Contamination of the skin of the fingers with tobramycin may lead to falsely increased measurements of serum levels of the drug.

This contamination cannot be completely avoided by hand washing before testing. Laboratory tests of urine and renal function should be conducted at the discretion of the treating physician.

Aminoglycosides can cause fetal harm when administered to a pregnant woman. Aminoglycosides cross the placenta, and streptomycin has been associated with several reports of total, irreversible, bilateral congenital deafness in pediatric patients exposed in utero.

Patients who use Tobi Podhaler during pregnancy, or become pregnant while taking Tobi Podhaler should be apprised of the potential hazard to the fetus [see Use in Specific Populations 8.

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Tobi Podhaler has been evaluated for safety in cystic fibrosis patients exposed to at least one dose of Tobi Podhaler, including patients who were exposed across three cycles 6 months of treatment.

Each cycle consisted of 28 days on-treatment with mg administered twice-daily and 28 days off-treatment.

There were males and females in this population, and reflecting the cystic fibrosis population in the U.

The primary safety population reflects patients from Study 1, an open-label study comparing Tobi Podhaler with TOBI tobramycin inhalation solution, USP over three cycles of 4 weeks on treatment followed by 4 weeks off treatment.

Randomization, in a planned ratio, resulted in patients treated with Tobi Podhaler and patients treated with TOBI. The mean age for both arms was between 25 and 26 years old.

Adverse drug reactions are listed according to MedDRA system organ class and sorted within system organ class group in descending order of frequency.

The supportive safety population reflects patients from two studies: Study 2, a double-blind, placebo-controlled design for the first treatment cycle, followed by all patients receiving Tobi Podhaler replaced placebo for two additional cycles, and Study 3, a double-blind, placebo-controlled trial for one treatment cycle only.

Placebo in these studies was inhaled powder without the active ingredient, tobramycin. The patient population for these studies was much younger than in Study 1 mean age 13 years old.

Adverse drug reactions reported more frequently by Tobi Podhaler patients in the placebo-controlled cycle Cycle 1 of Study 2, which included 46 Tobi Podhaler and 49 placebo patients, were:.

Respiratory, thoracic, and mediastinal disorders. Pharyngolaryngeal pain Tobi Podhaler Adverse drug reactions reported more frequently by Tobi Podhaler patients in Study 3, which included 30 Tobi Podhaler and 32 placebo patients, were:.

In Study 2, no patients reported hearing complaints but two Tobi Podhaler patients met the criteria for ototoxicity. In some patients, ototoxicity was transient or may have been related to a conductive defect.

There was a higher rate of cough adverse event reporting during the first week of active treatment with Tobi Podhaler i.

In some patients, cough resulted in discontinuation of Tobi Podhaler treatment. In Study 2, cough was the most commonly reported adverse event during the first cycle of treatment the double blind period of treatment and occurred more frequently in placebo-treated patients Similar percentages of patients in both treatment groups reported cough as a baseline symptom.

The following adverse reactions have been identified during postapproval use of Tobi Podhaler. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

No clinical drug interaction studies have been performed with Tobi Podhaler. In clinical studies, patients receiving Tobi Podhaler continued to take dornase alfa, bronchodilators, inhaled corticosteroids, and macrolides.

No clinical signs of drug interactions with these medicines were identified. Some diuretics can enhance aminoglycoside toxicity by altering antibiotic concentrations in serum and tissue.

Tobi Podhaler should not be administered concomitantly with ethacrynic acid, furosemide, urea, or intravenous mannitol.

The interaction between inhaled mannitol and Tobi Podhaler has not been evaluated. No reproduction toxicology studies have been conducted with Tobi Podhaler.

Ototoxicity was not evaluated in offspring during nonclinical reproduction toxicity studies with tobramycin.

Aminoglycosides can cause fetal harm e. No adequate and well-controlled studies of Tobi Podhaler in pregnant women have been conducted.

If Tobi Podhaler is used during pregnancy, or if the patient becomes pregnant while taking Tobi Podhaler, the patient should be apprised of the potential hazard to the fetus.

The amount of tobramycin excreted in human breast milk after administration by inhalation is not known. Because of the potential for ototoxicity and nephrotoxicity in infants, a decision should be made whether to terminate nursing or discontinue the drug, taking into account the importance of the drug to the mother.

Patients 6 years and older were included in the Phase 3 studies with Tobi Podhaler; patients below 20 years of age received Tobi Podhaler.

No dosage adjustments are needed based on age. The overall pattern of adverse events in pediatric patients was similar to the adults.

Dysgeusia taste disturbance was more commonly reported in younger patients six to 19 years of age than in patients 20 years and older, 7.

Safety and effectiveness in pediatric patients below the age of 6 years have not been established. Clinical studies of Tobi Podhaler did not include sufficient numbers of subjects aged 65 years and over to determine whether they respond differently from younger subjects.

Tobramycin is known to be substantially excreted by the kidney, and the risk of adverse reactions to this drug may be greater in patients with impaired renal function.

Because elderly patients are more likely to have decreased renal function, it may be useful to monitor renal function [see Warnings and Precautions 5.

Tobramycin is primarily excreted unchanged in the urine and renal function is expected to affect the exposure to tobramycin.

The risk of adverse reactions to this drug may be greater in patients with impaired renal function. No studies have been performed in patients with hepatic impairment.

As tobramycin is not metabolized, an effect of hepatic impairment on the exposure to tobramycin is not expected.

Adequate data do not exist for the use of Tobi Podhaler in patients after organ transplantation. In the event of accidental oral ingestion of Tobi Podhaler capsules, systemic toxicity is unlikely as tobramycin is poorly absorbed.

Tobramycin serum concentrations may be helpful in monitoring overdosage. Acute toxicity should be treated with immediate withdrawal of Tobi Podhaler, and baseline tests of renal function should be undertaken.

In all cases of suspected overdosage, physicians should contact the Regional Poison Control Center for information about effective treatment.

In the case of any overdosage, the possibility of drug interactions with alterations in drug disposition should be considered.

Tobi Podhaler consists of a dry powder formulation of tobramycin for oral inhalation only with the Podhaler device. The inhalation powder is filled into clear, colorless hypromellose capsules.

Each clear, colorless hypromellose capsule contains a spray dried powder of 28 mg of tobramycin active ingredient with 1,2-distearoyl-sn-glycerophosphocholine DSPC , calcium chloride, and sulfuric acid for pH adjustment.

The active component of Tobi Podhaler is tobramycin. Tobramycin is an aminoglycoside antibiotic.

Tobramycin has a molecular weight of Tobramycin is a white to almost white powder; visually free from any foreign contaminants.

Tobramycin is freely soluble in water, very slightly soluble in ethanol, and practically insoluble in chloroform and ether.

The Podhaler device is a plastic device used to inhale the dry powder contained in the Tobi Podhaler capsule.

Peak inspiratory flow rate and inhaled volumes were explored in 96 cystic fibrosis patients aged 6 years and older. Tobramycin is an aminoglycoside antibiotic [see Clinical Pharmacology Tobi Podhaler contains tobramycin, a cationic polar molecule that does not readily cross epithelial membranes.

Tobi Podhaler is specifically formulated for administration by oral inhalation. The systemic exposure to tobramycin after inhalation of Tobi Podhaler is expected to result from pulmonary absorption of the dose fraction delivered to the lungs as tobramycin and is not absorbed to any appreciable extent when administered via the oral route.

After inhalation of a mg single dose 4 times 28 mg capsules of Tobi Podhaler in cystic fibrosis patients, the maximum serum concentration C max of tobramycin was 1.

The extent of systemic exposure AUC was also similar: 4. At the end of a 4-week dosing cycle of Tobi Podhaler mg twice-daily , the maximum serum concentration of tobramycin 1 hour after dosing ranged from 1.

The variability in pharmacokinetic parameters was higher in sputum as compared to serum. A population pharmacokinetic analysis for Tobi Podhaler in cystic fibrosis patients estimated the apparent volume of distribution of tobramycin in the central compartment to be Tobramycin is eliminated from the systemic circulation primarily by glomerular filtration of the unchanged compound.

Systemically absorbed tobramycin following Tobi Podhaler administration is also expected to be eliminated principally by glomerular filtration.

The apparent terminal half-life of tobramycin in serum after inhalation of a mg single dose of Tobi Podhaler was approximately 3 hours in cystic fibrosis patients and consistent with the half-life of tobramycin after TOBI inhalation.

A population pharmacokinetic analysis for Tobi Podhaler in cystic fibrosis patients aged 6 to 58 years estimated the apparent serum clearance of tobramycin to be No clinically relevant covariates that were predictive of tobramycin clearance were identified from this analysis.

Tobramycin is an aminoglycoside antimicrobial produced by Streptomyces tenebrarius. It acts primarily by disrupting protein synthesis leading to altered cell membrane permeability, progressive disruption of the cell envelope, and eventual cell death.

Tobramycin has in vitro activity against Gram-negative bacteria including P. It is bactericidal in vitro at peak concentrations equal to or slightly greater than the minimum inhibitory concentration MIC.

Interpretive criteria for inhaled antibacterial products are not defined. The in vitro antimicrobial susceptibility test methods used to determine the susceptibility for parenteral tobramycin therapy can be used to monitor the susceptibility of P.

A single sputum sample from a cystic fibrosis patient may contain multiple morphotypes of P. Patients should be monitored for changes in tobramycin susceptibility.

In clinical studies, some increases from baseline to the end of the treatment period were observed in the tobramycin MIC for P.

In general, a higher percentage of patients treated with Tobi Podhaler had increases in tobramycin MIC compared with placebo or patients treated with TOBI inhalation solution.

The clinical significance of changes in MICs for P. Some emerging resistance to aztreonam, ceftazidime, ciprofloxacin, imipenem, or meropenem were observed in the Tobi Podhaler clinical trials.

As other anti-pseudomonal antibiotics were concomitantly utilized in many patients in the clinical trials, the association with Tobi Podhaler is not clear.

No trends were observed in the isolation of treatment-emergent bacterial respiratory pathogens Burkholderia cepacia, Stenotrophomonas maltophilia, Staphylococcus aureus, and Achromobacter xylosoxidans.

Carcinogenicity studies were not conducted with Tobi Podhaler. A 2-year rat inhalation toxicology study to assess carcinogenic potential of TOBI tobramycin inhalation solution, USP has been completed.

Rats were exposed to TOBI for up to 1. There was no drug-related increase in the incidence of any variety of tumor.

Additionally, tobramycin has been evaluated for genotoxicity in a battery of in vitro and in vivo tests. The Ames bacterial reversion test, conducted with 5 tester strains, failed to show a significant increase in revertants with or without metabolic activation in all strains.

Tobramycin was negative in the mouse lymphoma forward mutation assay, did not induce chromosomal aberrations in Chinese hamster ovary cells, and was negative in the mouse micronucleus test.

The Phase 3 clinical development program included two placebo-controlled studies Studies 2 and 3 and one open-label study Study 1 , which randomized and dosed and patients, respectively, with a clinical diagnosis of cystic fibrosis, confirmed by quantitative pilocarpine iontophoresis sweat chloride test, well-characterized disease causing mutations in each CFTR gene, or abnormal nasal transepithelial potential difference characteristic of cystic fibrosis.

In addition, all patients were infected with P. Thirty-six patients were between 6 and 12 years of age, and 40 patients were between 13 and 21 years of age.

The most frequently used other antibacterial drugs any route of administration were azithromycin, ciprofloxacin, and ceftazidime.

Study 2 was a randomized, 3-cycle, 2-arm trial. Each cycle comprised of 28 days on treatment followed by 28 days off treatment.

The first cycle was double-blind, placebo-controlled with eligible patients randomized to Tobi Podhaler 4 times 28 mg capsules twice-daily or placebo.

Upon completion of the first cycle, patients who were randomized to the placebo treatment group received Tobi Podhaler for Cycles 2 and 3.

Trebuie avute in vedere ghidurile oficiale de utilizare corespunzatoare a antibioticelor. Conditii de pastrare : La temperaturi intre grade celsius.

TOBI este sensibil la lumina puternica. Dupa ce este scos din frigider sau daca refrigerarea lui nu mai este posibila. TOBI poate fi pastrat la temperaturi sub 25 grade Celsius cel mult 28 zile.

Reactii adverse : In studii clinice controlate. Episoadele de tinitus au fost trecatoare si s-au remis fara a se intrerupe tratamentul cu TOBI; conform audiogramelor acestea nu au fost asociate cu pierderea permanenta a auzului.

Riscul aparitiei de tinitus nu a crescut in cazul administrarii de TOBI in cicluri repetate. Alte reactii adverse.

In perioada de dupa punerea pe piata. Foarte rare: dureri abdominale. Aparat digestiv: Rare: greata.

Foarte rare: diaree. Sange si sistem limfatic: Foarte rare: limfoadenopatie. Sistem nervos: Rar: ameteli.

Foarte rae: somnolenta. Aparat respirator: Mai putin frecvente: afectarea vocii inclusiv disfonie.

Rare: bronhospasm. Foarte rare: hiperventilatie. Organe de simt: Rare: tinitus. Foarte rare: tulburari la nivelul aparatului acustic.

Tegumente si fanere: Rare: rash. Asa cum reiese din studiile clinice deschise si din experienta de dupa punerea pe piata a medicamentului.

Administrarea parenterala de aminoglicozide a fost asociata cu reactii de hipersensibilitate. Contraindicatii : Administrarea TOBI este contraindicata pacientilor care au hipersensibilitate la aminoglicozide sau la oricare dintre excipienti.

Precautii : TOBI trebuie folosit cu atentie la pacientii care sunt suspectati sau se cunoaste ca au disfunctii renale. Concentratia plasmatica a tobramicinei va fi monitorizata din probe de sange recoltate prin punctie venoasa si nu prin recoltarea probelor din deget.

S-a observat ca datorita contaminarii degetelor cu tobramicina in timpul prepararii si administrarii TOBI se pot obtine rezultate false ale unor concentratii plasmatice crescute de tobramicina.

Aceasta contaminare nu poate fi evitata complet prin spalarea mainilor inainte de recolatre. Bronhospasm: Bronhospasmul poate sa apara odata cu inhalarea medicamentelor si a fost raportat in cazul nebulizarii tobramicinei.

Prima doza trebuie adimnistrata sub supraveghere. FEV1 trebuie masurat inainte si dupa nebulizare. Daca exista indicii ca tratamentul va provoca un bronhospasm pacientului caruia nu i se administreaza un bronhodilatator.

Aparitia bronhospasmului in prezenta tratamentului cu bronhodilatator poate indica o reactie alergica. In acest caz administrarea de TOBI trebuie intrerupta.

Bronhospasmul trebuie tratat corespunzator. Tulburari neuromusculare: TOBI trebuie administrat cu mare atentie pacientilor cu tulburari neuromusculare cum ar fi: boala Parkinson sau alte afectiuni caracterizate prin miastenie.

Nefrotoxicitate: Desi nefrotoxicitatea a fost asociata cu tratamentul parenteral cu aminoglicozide. Medicamentul trebuie administrat cu prudenta pacientilor cu disfunctii renale suspectate sau cunsocute si este necesara monitorizarea concentratie plasmatice de tobramicina.

Pacientii cu afectare renala severa. Practica clinica curenta impune evaluarea functiilor renale inainte de inceperea tratamentului.

Concentratia plasmatica de uree si creatinina trebuie reevaluate dupa fiecare 6 cicluri de tratament cu TOBI de zile de tratament cu nebulizare a amniglocizidei.

Daca exista indicii privind existenta unei nefrotoxicitati. In aceasta situatie tratamentul cu TOBI se poate continua conform prescriptiei medicului curant.

Pacientii care primesc concomitent tratament parenteral cu aminoglicozide. Ototoxicitate: Ototoxicitatea. Efectul toxic la nivel vestibular se poate manifesta prin vertij.

In conformitate cu evaluarile atat a sesizarilor pacientilor privind pierderea auzului cat si a valorilor audiometrice in cazul administrarii tratamentului cu TOBI in cursul studiilor clinice controlate.

Medici trebuie sa ia in considerare potentialul aminoglicozidelor de a exercita efect toxic la nivelul aparatului acustico-vestibular si sa acorde atentia necesara pentru estimarea functiei auditive pe durata tratamentului cu TOBI.

Inainte de a incepe administrarea de TOBI la pacientii cu risc datorat unui tratament anterior indelungat cu aminoglicozide.

Aparitia brusca de tinitus. Daca pacientul reclama tinitus sau pierderea auzului in cursul tratamentului cu aminoglicozide.

Pacientii carora li se administreaza concomitent.

Tobi Toxic

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